NCT01434836

Brief Summary

The goal of this project is to train currently major depressed patients on fundamental aspects of working memory while the investigators administer transcranial Direct Current Stimulation (tDCS) over the left dorsolateral prefrontal cortex (DLPFC) during these training sessions. This working memory training would be performed using adaptive Paced Auditory Serial Addition Tasks (PASAT). The effects after two weeks of working memory training combined with tDCS or sham placebo (10 sessions) will be measured on different variables, each measured at the start and at the end of the two weeks of training. The investigators expect the greatest anti depressant results and cognitive enhancements in the group of depressed patients that received tDCS combined with working memory training.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2 depression

Timeline
Completed

Started Sep 2011

Shorter than P25 for phase_2 depression

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

September 9, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 15, 2011

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

June 3, 2013

Status Verified

May 1, 2013

Enrollment Period

1.7 years

First QC Date

September 9, 2011

Last Update Submit

May 30, 2013

Conditions

Depression

Keywords

Anti-depressant effects

Outcome Measures

Primary Outcomes (1)

  • Hamilton Depression Rating Scale

    The primary outcome measure is the score of HDRS-24 scale after 4 weeks of treatment.

    4 weeks

Secondary Outcomes (6)

  • Beck Depression Inventory

    4 weeks

  • follow-up measure

    after two weeks

  • Internal Shift Task

    2 weeks

  • Working memory task in combination with pupil dilatation

    2 weeks

  • Heart Rate Variability

    2 weeks

  • +1 more secondary outcomes

Study Arms (2)

active tDCS and working memory training

ACTIVE COMPARATOR
Other: active tDCS and working memory training

sham tDCS and working memory training

PLACEBO COMPARATOR
Other: sham tDCS and working memory training

Interventions

active tDCS and working memory trainingOTHER

This group will receive 2.0 mA anodal DC stimulation over the left DLPFC and cathodal stimulation over the right DLPFC. During the stimulation, this group will be trained on working memory processes. Sessions will be scheduled daily for two consecutive weeks.

active tDCS and working memory training
sham tDCS and working memory trainingOTHER

This group will receive sham stimulation (e.g., identical stimulation set-up but no electric current is sent through the electrodes). Patients however receive the real working memory training, daily, for two weeks.

sham tDCS and working memory training

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Depressive Disorder, Major (SCID)
  • HDRS-24 \> 21

You may not qualify if:

  • Other axis I disorders, including Bipolar Disorder, Schizophrenia, Substance Abuse Disorders.
  • Any axis II disorders.
  • Any serious/life-threatening axis III disorders, such as Congestive Heart Failure, Pulmonary Obstructive Chronic Disease, Active Neoplasia.
  • Neurological diseases such as Stroke (and Post-Stroke Depression), Dementias and others.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of São Paulo, Hospital Universitário

São Paulo, São Paulo, 05508-000, Brazil

Location

Universidade Presbiteriana Mackenzie

São Paulo, São Paulo, Brazil

Location

Related Publications (1)

  • Brunoni AR, Boggio PS, De Raedt R, Bensenor IM, Lotufo PA, Namur V, Valiengo LC, Vanderhasselt MA. Cognitive control therapy and transcranial direct current stimulation for depression: a randomized, double-blinded, controlled trial. J Affect Disord. 2014 Jun;162:43-9. doi: 10.1016/j.jad.2014.03.026. Epub 2014 Mar 27.

    PMID: 24767004DERIVED

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Andre R Brunoni, MD

    University of Sao Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Associate

Study Record Dates

First Submitted

September 9, 2011

First Posted

September 15, 2011

Study Start

September 1, 2011

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

June 3, 2013

Record last verified: 2013-05

Locations

BR(2)